Steps required to recruit to DAMASCUS
- DAMASCUS patient inclusion window open
The recruitment window for DAMASCUS opened on 1st October but we recognise that as a global study a single start date that suits everyone is impossible in the current climate so there is a rolling start date from 1st October. Once you have permission at your hospital you should start tracking eligible patients and recording their data for a minimum of 6 consecutive months, followed by six months follow up. We anticipate that the site opening window, when new sites will still be able to join the study, will be open for at least 3-4 months and potentially longer depending on progress.
- Data collection
For centres that are already uploading data to the study database remember to record the patient REDCap ID against a hospital identifier and maintain this link information securely at your hospital site.
If you do not have a login to the study database in REDCap you may still start tracking and recording the details of eligible patients on paper if you have permission from your hospital. Hard copy CRFs are attached to this email.
- Still getting approvals in place, can we help?
In the UK DAMASCUS is registered as an audit. In some other countries you may need to register with your local research department. If you are not sure about how to register the study in your country please contact us and we will put you in touch with your national study lead who should help you with your local registration. The latest study protocol can be downloaded from here and you can also find more information to help with your local registration at the study website.
Confirmation of local registration is essential to receive a login to the study database, however if you have permission from your hospital you may start to track and record eligible patients on paper.
- Our team details have changed / I’ve moved hospitals and would like to sign up a new centre to take part in DAMASCUS
Given the 6-month follow up of this audit, we appreciate that data collection will likely cross over training rotations. Please contact us through this link to let us know about any changes to your team throughout the study (each team can have up to 10 collaborators).
If you’ve moved hospitals since initially signing up to DAMASCUS and would like to take part from your new centre please form a local team and let us know your details through this link. Only one registration is required per site.
- Study database downtime on Thursday 29th October
BiSTC REDCap is being upgraded on Thursday 29th October and the DAMASCUS database will be unavailable between 7.30-10.00am BST.
Country leads for DAMASCUS
Country leads will coordinate the opening of recruiting sites in a single country, specifically, they will support local investigators by:
- Helping with local country-specific ethical applications/reviews
- Local translation of study documentation
- Coordinate communication with CI’s and the study centre
Requirements expected for the Country leads:
Successful country leads will:
- Open at least 3 centres in their country
- Each site will recruit at least 3 patients over the duration of the study i.e. one patient recruited every 2 months
The country leads will be acknowledged separately in presentation/publications. Hierarchically they will sit as follows:
- Study management group.
- Writing group.
- The country leads group (1 lead per country, more than 1 will be considered in countries that have a high volume of units i.e. over 12.
- Local investigators (up to 10 collaborators per site) and site lead investigators (denoted by an asterix*), organised by site – in alphabetical order, by country.
Details of country leads will soon be posted upon the Dukes Club website once a finalised list has been compiled.
Finally, it is not too late to join DAMASCUS if you haven’t done already. Your hospital can take part in this international project aiming to improve the management of diverticular disease. If you would like your hospital to join, please fill the REDCap registration through this link.
COVID updates to eCRF
Given that some recruitment will take place during COVID surges we have added a few questions to the CRF that briefly cover whether COVID status (patient or unit) influence management of patients at any point.
- Download DAMASCUS protocol
Frequently Asked Questions
- Who is already involved?
- There are over 110 sites signed up across the world. Please contact us if your hospital has signed up and you wish to join the team at your hospital.
- Sign me up!
- Please use this link to register your site to get REDCap login. We will issue REDCap logins to centres who have local approval confirmed.
- Do I need to get ethical approval to join the study?
- Ethical approval will be sought within each host nation according to local, state or national policy.
- In the UK, this audit is not considered to be research and as such sites will be able to participate once local clinical audit approval is in place.
- You can download Mount Sinai’s IRB approved informed consent form (ICF) from here IRB-Approved-ICF
- Which guidelines I should use for the audit proposal?
- The EAES and SAGES 2018 consensus conference on acute diverticulitis management: evidence-based recommendations for clinical practice can be found here to be used for local audit registration.
- Who do I contact to get involved?
- For more information, please contact us at Damascus.firstname.lastname@example.org.
- If you need to present the study to your department, you may use this presentation if you wish.